Brand Name | MANUAL CONTROLLED COSYCOT INFANT WARMER |
Type of Device | FMT |
Manufacturer (Section D) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ 2013 |
|
Manufacturer (Section G) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ
2013
|
|
Manufacturer Contact |
faranak
gomarooni
|
173 technology drive |
suite 100 |
irvine, ca
|
4534000142
|
|
MDR Report Key | 9892459 |
MDR Text Key | 187427461 |
Report Number | 9611451-2020-00305 |
Device Sequence Number | 1 |
Product Code |
FMT
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K971695 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
02/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IW950 |
Device Catalogue Number | IW950 |
Device Lot Number | 040227 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/27/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2004 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |